ERAS Swallowing Rehabilitation in Elder Patients

NCT ID: NCT05999786

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2030-12-31

Brief Summary

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The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery.

Detailed Description

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The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery requiring tracheal intubation will be recruited. Patients will be randomized into an intervention and a control group. Patients in the intervention groups will received the ERAS-W program, while those in the control group will receive the swallowing education video.

Conditions

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The Upper Esophageal Sphincter Contraction Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients receive early recovery of swallowing rehabiliation before surgery and continued to after surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Data manager knows whether the patients are in the intervention or control group. However, the patients, caregiver, investigator, and outcome assessors do not know whether the patients are in the intervention or control group.

Study Groups

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patients receiving early rehabiliation swallowing program

the early rehabilitation program beginning from before to after surgery

Group Type ACTIVE_COMPARATOR

early rehabiliation swallowing program

Intervention Type BEHAVIORAL

not receiving early rehabilitation swallowing program from before and after surgery

patients not receiving early rehabilitation swallowing program

the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is started from before to after surgery

Group Type PLACEBO_COMPARATOR

not receiving early rehabilitation swallowing program

Intervention Type BEHAVIORAL

the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery

Interventions

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early rehabiliation swallowing program

not receiving early rehabilitation swallowing program from before and after surgery

Intervention Type BEHAVIORAL

not receiving early rehabilitation swallowing program

the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* elective surgery
* general anesthesia with endotracheal intubation

Exclusion Criteria

* major organ dysfunction, ex: chronic kidney disease, hear failure
* bleeding tendency
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Clinical Trial Center

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Chih-Min Liu, MD

Role: CONTACT

_886-972652224

Chih-Jun Lai, MD

Role: CONTACT

+886-972652086

Other Identifiers

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202303005RIND

Identifier Type: -

Identifier Source: org_study_id

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